| A -- Newborn Screening Translational Research Network Coordinating Center Description |
| Program Summary |
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| Title: |
A -- Newborn Screening Translational Research Network Coordinating Center Description |
| GovCB Opps ID : |
ADP11969079760000998 |
| Document Type: |
Sources Sought Notice |
| FSC Code: |
A - Research and development
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| NAICS Code: |
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| Solicitation No.: |
Reference-Number-NICHD-MRDD-Newborn |
| Source: |
http://www2.fbo.gov/spg/HHS/NIH/NICHD/Reference%2DNumber%2DNICHD%2DMRDD%2DNewborn/Synops... |
Place of
Performance: |
Address: 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD Postal Code: 20892-7510 Country: UNITED STATES
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Posted Date:
|
Dec 05, 2007 |
| Last Update: |
Dec 05, 2007 |
| Due Date: |
Dec 20, 2007 |
|
| Description |
|
General Information
| Document Type: |
Sources Sought Notice |
| Solicitation Number: |
Reference-Number-NICHD-MRDD-Newborn |
| Posted Date: |
Dec 05, 2007 |
| Original Response Date: |
Dec 20, 2007 |
| Current Response Date: |
Dec 20, 2007 |
| Original Archive Date: |
Jan 04, 2008 |
| Current Archive Date: |
Jan 04, 2008 |
| Classification Code: |
A -- Research & Development |
| Naics Code: |
541711 -- Research and Development in Biotechnology |
Contracting Office Address
Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510, UNITED STATES
Description
Sources of Sought
Newborn Screening Translational Research Network Coordinating Center Description
Background:
The Mental Retardation and Developmental Disabilities Branch (MRDD) within the Center for Developmental Biology and Perinatal Medicine (CDBPM) of the National Institute of Child Health and Human Development (NICHD) is interested in identifying any organization with the requisite capabilities to develop and maintain a Coordinating Center that will establish the research infrastructure for a Newborn Screening Translational Research Network (NBSTRN).
Newborn screening is currently used to identify afflicted infants prior to presentation of clinical symptoms of disease. It is the most common form of population-based genetic testing, screening 4 million newborn infants annually in the United States. Recently there has been a rapid expansion of the number of conditions included in state newborn screening panels however, evidenced-based research to support the inclusion of these candidate conditions is lacking. Specifically there is a need to understand the natural history of these candidate conditions, explore technological capabilities of screening assays, and develop therapeutic interventions for these conditions.
Newborn screening is considered a coordinated and comprehensive system that includes education, screening, follow-up, diagnosis, management and program evaluation. This public health program is under the auspice of each state, thus newborn screening policy is decided at the state level. There are limited federal policies on newborn screening. Since policies are made at the state level, there is wide state-to-state variability on which disorders are included on state newborn screening panels.
The standard for states in determining which conditions to screen for has largely remained unchanged since 1968. In general, the conditions screened for should be an important health problem, with an acceptable and accessible treatment, the natural history of the condition should be known and there should be a suitable test that?s acceptable to the population and is appropriately sensitive and specific. Many of the conditions currently screened for do not fulfill all the criteria and decisions have been made based on other factors. Decisions about which tests to use in newborn screening programs often have been made in an extemporaneous fashion, depending on recommendations from professional groups, patient advocates, state legislators, and newborn screening programs.
There is a tremendous need for surveillance and research to provide the evidence needed for state-level decisions and to develop nationally recognized standards. In order to execute this type of research responsibly a comprehensive research infrastructure is needed. Currently no such research infrastructure exists, so therefore, the NICHD proposes to establish a research infrastructure for a Newborn Screening Translational Research Network (NBSTRN).
Objective:
The primary purposes of the NBSTRN Coordinating Center is to provide an infrastructure for research that facilitates the development of new screening methods, clinical trials for new therapeutic interventions and support longitudinal research to study the long-term health of children identified through newborn screening. The NBSTRN Coordinating Center is the first and critical element for development and implementation of the NBSTRN. This center will be responsible for the coordination of all research protocols, the development of the informatics system and virtual repository of residual dried bloodspots, the management of a steering committee, and the standardization of necessary informed consent policies and practices. Planning for the development of the network?s infrastructure will occur during the first three years of the contract, including development of the informatics component and protocol development.
The Coordinating Center is intended to support the following goals of the NBSTRN:
1) Address the needs of biomedical investigators across the country to effectively share and have access to dried bloodspots and other samples including possibly enrolled patients in a site-independent manner for research.
2) Facilitate evaluating the predictive value of biomarkers through early phase clinical/epidemiological studies.
3) Encourage collaboration and rapid dissemination of information to ensure progress and avoid fragmentation of effort.
4) Facilitate research on the development of new methods and technologies.
5) Facilitate research on screened and treated patients to define effectiveness of treatments and long-term outcomes.
Requirements:
To be deemed capable of developing and maintaining the NBSTRN Coordinating Center the offeror must submit a written capability statement that clearly demonstrates their experience and ability to:
1) Develop laboratory and practice standards guidelines related to newborn screening.
2) Provide expert professional leadership in the laboratory and clinical diagnosis of conditions included in newborn screening.
3) Develop and provide access to residual dried bloodspots comprising of those stored by State newborn screening programs and/or other repositories.
4) Develop an informatics and communications system to link researchers to potential human subjects for clinical trials, follow up and other research issues and activities.
5) Develop recommendations for model informed consent and research policies appropriate to newborn screening.
6) Function productively as an organized and established center of state newborn screening programs and clinical centers to validate screening technologies and therapeutic interventions.
AT THIS TIME THE NICHD IS REQUESTING CAPABILITY STATEMENTS FROM ALL QUALIFIED BUSINESSES. THIS ANNOUNCEMENT IS NOT A REQUEST FOR PROPOSAL. The applicable North American Industry Classification System (NAICS) code for this requirement would be 541711.
All qualified businesses, who believe that they have the capabilities described above are encouraged to submit two copies of written Capability Statement to attention of Allison Young, Contract Specialist (Email Address ? YoungAllison@niddk.nih.gov) or at the address provided by 3:00 PM Local Time on December 20, 2007. The address where the capability statements should be mailed to is: Office of Acquisitions, NIDDK, NICHD Branch, NIH, Executive Building, Room 7A-07, 6100 Executive Blvd., MSC 7540, Bethesda, Maryland 20892. The Capability Statement should be limited to no more than 25 pages and it should clearly address each of the competencies stated above.
NO COLLECT CALLS WILL BE ACCEPTED. RESPONDENTS MAY SUBMIT THEIR CAPABILITY STATEMENTS VIA E-MAIL IN PORTABLE DOCUMENT FORMAT (PDF). SEE NUMBER NOTE 25.
Point of Contact
Allison Young, Contract Specialist, Phone 301-435-6958, Fax 301-402-3676, Email youngallison@niddk.nih.gov - Ross Kelley, Contracting Officer, Phone 301-435-6960, Fax 301-402-3676, Email rk17a@nih.gov
Place of Performance
| Address: |
6100 Executive Blvd., Suite 7A07, MSC7510,
Bethesda, MD |
| Postal Code: |
20892-7510 |
| Country: |
UNITED STATES |
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